Table 4.

Safety Outcomes in Patients Treated with Simeprevir and Sofosbuvir

Reason	CP Class B/C (n = 55)	CP Class A (n = 101)
Early Treatment Discontinuation due to Adverse Event (n=6)*
Infection and hepatic decompensation, no (%)	3 (50)	0 (0)
Skin/soft tissue infection, no	1	0
Cholangitis, no	1	0
Infection, no (%)	1 (17)	0 (0)
Bacteremia (unclear source), no	1	0
Hepatic decompensation, no (%)	1 (17)	1 (17)
De novo B-cell lymphoma, no (%)	1 (17)	0 (0)
Hospitalization due to Adverse Event (n=14)
Infection and hepatic decompensation, no (%)	4 (29)	0 (0)
Skin/soft tissue infection, no	1	0
Bursitis, no	1	0
Cholangitis, no	1	0
Urinary tract infection, Pneumonia, Dental abscess, no	1	0
Infection, no (%)	3 (21)	0 (0)
Skin/soft tissue infection, no	2	0
Bacteremia (unclear source), no	1	0
Hepatic decompensation, no (%)	3 (21)	0 (0)
Other, no (%)	2 (14)	2 (14)
Rash, no	1	0
Headache, no	0	1
Gout, no	0	1
Hypoglycemia in diabetic, no	1	0
Infection Requiring Antibiotics (n=12)
Skin/soft tissue infection, no (%)	5 (42)	2 (17)
Bursitis, no (%)	1 (8)	0 (0)
Cholangitis, no (%)	1 (8)	0 (0)
Bacteremia (unclear source), no (%)	1 (8)	0 (0)
Urinary tract infection, Pneumonia, Dental abscess, no (%)	1 (8)	0 (0)
Urinary tract infection, no (%)	2 (17)	0 (0)
Hepatic Decompensation (n=14)
Hepatic encephalopathy, no (%)	7 (50)	2 (14)
Ascites, no (%)	3 (21)	1 (7)
Variceal bleed, no (%)	1 (7)	0 (0)
Death (n=2)
Hepatic decompensation with seizures, no (%)	1 (50)	0 (0)
Non-Hodgkins lymphoma, present pre-treatment, no (%)	0 (0)	1 (50)

^*One patient discontinued treatment early not due to an adverse event. Due to “forgot to take medications” in a patient with CP-B/C cirrhosis and baseline hepatic encephalopathy

CP = Child-Pugh